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Evaluation of a Standardised Orientation and Mobility Training in Older Adults With Low Vision

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ClinicalTrials.gov Identifier: NCT00946062
Recruitment Status : Completed
First Posted : July 24, 2009
Last Update Posted : November 15, 2013
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
Maastricht University Medical Center

Brief Summary:

The purpose of this study is:

  1. to develop a standardised orientation and mobility training (O&M-training) in the use of an identification/symbol cane by older adults with low vision, and;
  2. to evaluate this newly developed standardised O&M-training with respect to effectiveness and feasibility in a randomised controlled trial.

Condition or disease Intervention/treatment Phase
Low Vision Aged Other: orientation and mobility training Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 190 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Impact of Orientation and Mobility Training on Mobility, Participation and Quality of Life in Older Adults With Visual Impairments: a Randomised Controlled Trial
Study Start Date : November 2007
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Arm Intervention/treatment
Active Comparator: regular O&M-training
orientation and mobility training in use of the identification cane as provided by mobility trainers
Other: orientation and mobility training
orientation and mobility training
Experimental: standardised O&M-training
standardised orientation and mobility training in use of the identification cane as provided by mobility trainers who received instruction in using the standardised protocol
Other: orientation and mobility training
orientation and mobility training



Primary Outcome Measures :
  1. activities of daily life (subscale of the Groningen Activity Restriction Scale (GARS)) [ Time Frame: 5 and 17 weeks ]
  2. distance activities and mobility (subscales of the Visual Functioning Questionnaire (VFQ)) [ Time Frame: 5 and 17 weeks ]

Secondary Outcome Measures :
  1. activities index (Frenchay Activities Index (FAI)) [ Time Frame: 5 and 17 weeks ]
  2. social support interactions (Social Support List (SSL 12-I)) [ Time Frame: 5 and 17 weeks ]
  3. health-related quality of life (EuroQol 5D (EQ5D)) [ Time Frame: 5 and 17 weeks ]
  4. mental health and dependency (subscale of the Visual Functioning Questionnaire (VFQ)) [ Time Frame: 5 and 17 weeks ]
  5. feelings of anxiety (anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A)) [ Time Frame: 5 and 17 weeks ]
  6. symptoms of depression (depression subscale of the Hospital Anxiety and Depression Scale (HADS-D)) [ Time Frame: 5 and 17 weeks ]
  7. concerns about falling (falls efficacy scale international (FES-I)) [ Time Frame: 5 and 17 weeks ]


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Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged 55 years or over
  • Low vision
  • Living independently in the community or in a home for older people
  • Able to see large obstacles and to go outside for a short walk or doing groceries
  • One of the following:

    1. experiencing difficulties with safely crossing a street
    2. experiencing difficulties with recognising acquaintances outdoors
    3. willing to become recognisable as being partially sighted by using the identification cane
  • Written informed consent
  • Orientation and Mobility training (O&M-training) in the use of an identification cane

Exclusion Criteria:

  • Cognitive impairment (a score of less than 4 on the Abbreviated Mental Test 4)
  • Language or hearing problems that impede completing an interview by telephone
  • Confinement to bed or possible nursing home admission that impede completion of the O&M-training
  • Permanent use of a walking aid incompatible with the use of an identification cane
  • Having recently received an O&M-training in the use of an identification cane and permanent use of this cane

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00946062


Locations
Netherlands
Sensis
Grave, Netherlands
Royal Visio
Huizen, Netherlands
Bartimeus
Utrecht, Netherlands
Sponsors and Collaborators
Maastricht University Medical Center
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
Principal Investigator: G.I.J.M. Kempen, PhD Maastricht University, CAPHRI School for Public Health and Primary Care

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT00946062     History of Changes
Other Study ID Numbers: MEC 07-3-057.5/pl
ZonMw 94305004
First Posted: July 24, 2009    Key Record Dates
Last Update Posted: November 15, 2013
Last Verified: November 2013

Keywords provided by Maastricht University Medical Center:
low vision
ophthalmology
randomised controlled trial
mobility
orientation
cane
aged

Additional relevant MeSH terms:
Vision, Low
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Eye Diseases
Signs and Symptoms